1. The Field of the Invention
The present invention relates to an analgesic treatment regimen comprising different dosage units separately adapted for administration as a function of an event or the time of day, packaged with indicia for clarity of identification of the dosage units, and with instructions for use of the dosage units together in a pain treatment regimen. The invention also relates to packaging having both the different dosage units.
2. The State of the Art
Time of day and activity (or event) are important, and often overlooked, considerations in the management of pain. For example, pain can interfere with sleep, and continued sleep deficit or interruption can aggravate the patient's condition and sensitivity to pain, in addition to taking its toll on the patient's general welfare.
An analgesic medication having (or formulated to have) stimulant properties has drawbacks when sleep or sedation is desired, even though such a pharmaceutical preparation may be an otherwise effective formulation for pain. Many commercially available formulations contain caffeine (or other stimulants) because of its known synergistic effect with certain analgesic compounds. However, the instructions given for these medications may be devoid of any appreciation for problems relating to the administration of such medications when sleep or sedation is desired or necessary. Accordingly, patients taking such medications may suffer from irritability, insomnia, and/or sleeplessness, which they and/or their physician usually fail to attribute to the analgesic medication.
It is often the case that a sedative action is desired to facilitate the patient's sleep and recuperation. Certain analgesic formulations are inherently sedating (or are likely to cause drowsiness in patients). These compositions are most suitable for administration when sedation or sleep is desired or is not contraindicated. Conversely, sedation imposes a risk in individuals engaged in activities requiring cognitive acuity, such as in the operation of motor vehicles or machinery, and clinical studies have demonstrated diminished cognitive and motor performance associated with even minimally sedating analgesic medications, notably in subjects who are not aware of being impaired.
Unexpected side effects are especially likely with over-the-counter analgesic medications. In part, this problem is caused by consumer inattentiveness to the labelling, which lists ingredients, dosages, likely side effects, and other contraindications and warnings. Consumers typically do not analyze the package indicia and often rely on the brand name and the advertising dress on the packaging as a guide to self-prescribing. The appropriateness of taking a particular analgesic medication with regard to stimulation or sedation, or during the day, night, or both is not always readily apparent from the advertising dress. For example, Excedrin Extra Strength (available from Bristol-Myers Products, New York, N.Y.) would appear to be appropriate for administration during the day or night. However, this formulation contains 65 mg of caffeine, a stimulant, and so is inappropriate for nighttime use or when sleep or sedation is desired, although the dosing instructions do not so state. As another example, Bayer, Bayer Maximum Strength, and Bayer Select Maximum Strength would all appear suitable for day or night use, but the last one contains caffeine. As yet another example, Midol, Maximum Strength Midol, Multisymptom Midol, Maximum Strength Multisymptom Midol, and Midol PMS would all appear suitable for day or night use; however, the second one listed contains caffeine and the last two contain an antihistamine having sedating effects. As still a further example, various medications for menstrual pain often contain a diuretic; taking such a medication before going to sleep can awaken the patient and reintroduce pain awareness, as well as rob the patient of necessary sleep because of the need to urinate, both due to the action of the diuretic.
The above-mentioned commercially available formulations are typical of the single entity medications, or medication formulations, presently sold over-the-counter or by prescription. None of these single dosage unit analgesic medications recommend use together with any other single dosage unit medication as a treatment regimen, nor do any of these single dosage unit analgesic medications contain instructions coordinating their use together with any other single dosage unit medication as a treatment regimen. All currently sold analgesic medications for relief of pain are single entity medications or single entity medication formulations which are available to a user either by over-the-counter sale or by prescription.
U.S. Pat. No. 3,515,265 discloses a unit dispenser for keeping track of the number of dosages of a particular medication which have or which are to be been taken.
U.S. Pat. No. 3,780,856 describes a device for use in hospitals to facilitate the administration of medications to a patients in which different medications are packaged in a 25.times.25 matrix of individual, detachable packages.
U.S. Pat. No. 4,038,937 describes a device for dispensing medications which includes a matrix of compartments correlated with indicia regarding the day of the week and the time of day the medication in a particular compartment is to be used.
U.S. Pat. No. 4,039,080 describes a tray for medicament pills having a matrix of compartments each associated with indicia regarding the day of the week and the time of day the medication in each compartment is to be taken.
U.S. Pat. No. 3,757,441 is directed to an article of manufacture for keeping a record of the times and days at which medicinal dosages are taken.
U.S. Pat. No. 4,295,567 (the disclosure of which is incorporated herein by reference) describes a medicament container for holding two dosage units which are symptomatic treatments for respiratory disorders, one dosage unit being indicated for daytime administration and being non-sedating, and the other dosage unit being indicated for nighttime administration and being sedating.
An important distinction should be drawn between analgesic medications and those used for treating respiratory disorders. Respiratory disorders pertain to the respiratory tract which includes the nasal passages, nasopharynx, bronchial tree, and pulmonary alveoli. Symptoms relating to these airways are primarily those of nasal congestion, sneezing, rhinorrhea, and post-nasal drip in the upper airways, and coughing, excess sputum production, wheezing, and shortness of breath, all associated with the lower airways. Medications for treating respiratory disorders therefore are those which reduce swelling of the respiratory passages, such as decongestants and antihistamines, those which decrease smooth muscle constriction such as xanthene bronchodilators, and those which facilitate mucous flow, such as mucolytics which thin secretions. These medications for treating respiratory disorders have no mode of action known to be associated with blocking the transmission or perception of pain, and so would not be considered useful in the treatment of tension or migraine headache, musculoskeletal pain such as present in backache and osteoarthritis, menstruation-related pain, or the pain of rheumatologic disorders.
Pain treatment for headache, musculoskeletal pain, menstruation-related pain, and rheumatologic disorders could be made more effective if medications that were primarily analgesic in nature were formulated to achieve additional therapeutic objectives, such as (i) reduction of anxiety, (ii) diuresis, (iii) vasoconstriction, (iv) reduction of inflammation, (v) relaxation of skeletal muscles, and/or (vi) induction of sleep in order to enhance the analgesic effect. Formulation of such analgesic compositions having multiple active ingredients used together requires careful appreciation of the individual and cumulative properties of the ingredients. A lay consumer choosing individual components is unlikely to achieve maximal therapeutic success and could risk harm from inappropriate dosing and unwanted side effects. The lay consumer choosing a multiplicity of dosage units for use together would have to glean information by muddling through a significant amount of fine print, the location and arrangement of which differs on the packages and/or inserts of the various analgesic manufacturers, to achieve the desired effect. Likewise, administration of a multiplicity of prescription medications suffers from a lack of coordinated dosing due to separate packaging and separate instructions for each medication. Thus, administration of multiple medications can result in incompatibility so that the desired analgesic effects are not achieved or so that the patient's condition is aggravated rather then relieved. Moreover, the use of multiple and various configured medications and packaging provide an increased risk of confusion, medication error, and lack of compliance.